MRX — System, Assisted Reproduction Laser Class II
Classification Details
- Product Code
- MRX
- Device Class
- Class II
- Regulation Number
- 884.6200
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202241 | hamilton thorne | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | July 2, 2021 |
| K192008 | vitrolife | LaserShot M, NaviLase | March 25, 2020 |
| K141434 | research instruments | SATURN 5 LASER | February 18, 2015 |
| K120055 | hamilton thorne | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED | April 24, 2012 |
| K083208 | research instruments | SATURN ACTIVE LASER SYSTEM | August 25, 2009 |
| K063636 | hamilton thorne biosciences | ZILOS-TK | April 24, 2007 |
| K060764 | research instruments | SATURN 3 LASER SYSTEM | March 12, 2007 |
| K062524 | minitube of america | OCTAX LASER SHOT SYSTEM | December 15, 2006 |
| K050768 | hamilton thorne biosciences | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | April 28, 2005 |
| DEN040009 | hamilton thorne biosciences | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) | November 4, 2004 |